Potential Thyrogen Contamination
2010-01-12 15:16:45
Submitted by: Alan Garber, MD, PhD
Editor, AACE Patient Safety Exchange
We have recently been notified that Thyrogen for injection by Genzyme contains, in rare instances (approximately 1% of vials), particulate contamination. Read More

Pancreatitis Now An Issue for DPP-4 Inhibitors
2009-10-05 16:42:52
Submitted by: Zachary T. Bloomgarden, MD, FACE
The FDA announced on September 25 that it is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on 88 post-marketing reported cases of acute pancreatitis in patients using these product Read More

Commentary on July 19 New York Times article on glucose monitor accuracy
2009-08-14 16:34:46
Submitted by: Richard Hellman, MD, FACP, FACE
As readers of this editorial series know, there is considerable concern from many quarters that the lower-than-optimal accuracy of glucose meters in current use, both in the inpatient and outpatient setting, is a cause of errors in insulin dosage, with res Read More

AACE Expands Interactions with FDA
2009-08-14 16:34:43
Submitted by: Alan Garber MD PhD
As part of its continuing outreach program to outside professional organizations, the US FDA has fostered collaborative interactions with a number of important professional organizations and societies, including AACE. Read More

AACE and the FDA
2009-08-14 16:34:40
Submitted by: Richard Hellman, MD, FACP, FACE
AACE's link with the FDA began almost three years ago, when the AMA, led by Dr. Michael Maves, their Executive Vice President and CEO, convened a meeting between senior FDA staff and a number of representatives of the medical specialty societies and began Read More

The July 2nd NEJM Correspondence regarding the NICE-SUGAR study – Were the better outcomes of the Van Den Berghe studies due to more accurate glucose meters used in point-of-care testing? Is patient safety for diabetes inpatients at risk in our hospitals with the methods in common use today?
2009-07-07 14:46:17
Submitted by: Richard Hellman, MD, FACP, FACE
A series of very provocative letters were published in the NEJM¹ regarding the results of the NICE-SUGAR study, but the most interesting was the one by Greet Van Den Berghe. In her letter, she pointed out four possible explanations for the disc Read More

Is there a link between Lantus (insulin glargine) and cancer? A commentary on reports from the FDA and the EASD on the possible association.
2009-07-02 15:42:54
Submitted by: Richard Hellman, MD, FACP, FACE
Recently, four articles and one letter were published in Diabetologica that set the diabetes world into a state of "high alert". The four articles, all observational studies and retrospective population studies, looked at the possible association Read More

Patient Safety Issues in the U.S – The dangers of an overly narrow focus
2009-06-24 11:41:18
Submitted by: Dr. Richard Hellman
One of the advantages of inpatient consultations in endocrinology and diabetes is that it allows an opportunity to see, in situ, the results of decisions made by others as they happen. One such example presented itself to me this morning. Read More

Insulin Pens and Safety – a suggestion from Dr. Irl Hirsch
2009-06-23 13:41:59
Submitted by: Dr. Richard Hellman
Dr. Irl Hirsch and his clinical staff brought up a problem related to two insulin pens made by Sanofi-Aventis. The Apidra Solostar is a slightly greyish-blue pen which is nearly identical in shape to the Lantus Solostar pen, which is grey with a lavender Read More

Patient Safety and Bilingualism
2009-06-23 13:40:32
Submitted by: Dr. Richard Hellman
At this year's annual meeting of the American Diabetes Association, several sessions were devoted to the barriers to care that can occur when a patient who does not speak English as their primary language is taken care of by a provider who speaks only Engl Read More

Patient Safety, Insulin Pumps, and Cognitive Dysfunction
2009-06-22 08:36:35
Submitted by: Dr. Richard Hellman
Earlier today, I consulted on a patient in the hospital who was there because of recurrent hypoglycemia. It was an interesting problem. The patient was an 85-year-old man, with a 39-year history of insulin dependent diabetes, who had been on an external Read More

The FDA Med-Watch Alert on Stolen Levemir – Is this just one example of a much bigger patient safety problem?
2009-06-17 16:22:39
Submitted by: Dr. Richard Hellman
On June 13^th, the FDA released a Public Health Advisory concerning Levemir, the long-acting insulin made by Novo Nordisk. Read More

New editorial by Dr David Cooper in Response to the FDA Safety Alert on Propylthiouracil
2009-06-08 08:49:53
Submitted by: Dr. David Cooper
On June 3, 2009 the FDA notified health-care professionals of the risk of serious liver injury, including liver failure and death with the use of propylthiouracil (PTU) in children and adults Read More

The FDA and AACE – Discussions on a new medication, Cycloset.
2009-05-29 14:42:58
Submitted by: Dr. Richard Hellman
Last week, the FDA engaged in a discussion with some of the AACE leadership about a new hypoglycemic agent, Cycloset, a quick-release low-dose formulation of bromocriptine mesylate, a dopamine agonist, which is thought to act centrally to reduce resistance Read More

The AACE/ADA Consensus Statement on Inpatient Glycemic Control and Patient Safety – What key points were made and what was still left unsaid?
2009-05-29 14:31:41
Submitted by: Dr. Richard Hellman
On May 8th, 2009, the AACE/ADA Consensus Statement on Inpatient Glycemic Control was published on-line, simultaneously in both Diabetes Care and Endocrine Practice. The ten-member panel of experts, co-chaired by Etie Moghissi and Mary Korytkowski, worked Read More

A recent report in JAMA on the association of hypoglycemia and dementia in older patients with type 2 diabetes – Is the link causal? And if so, in what direction is the causation?
2009-05-11 14:05:15
Submitted by: Dr. Richard Hellman
A recent article in JAMA by Whitmer et al reports on an association between the diagnosis of severe hypoglycemia and a subsequent diagnosis of dementia1. Read More

Dr. Hellman Comments on PTU Editorial
2009-04-22 14:12:07
Submitted by: Dr. Richard Hellman
The AACE Patient Safety Exchange is happy to publish an editorial by three distinguished endocrinologists regarding their well-documented and carefully constructed opinion on the safe use of antithyroid medication in pediatric populations. Read More

Propylthiouracil (PTU) Hepatotoxicity and Graves' Disease Therapy
2009-04-22 12:11:25
Submitted by:
...a significant problem related to the use of propylthiouracil (PTU) in children has come to light, as PTU use for the treatment of pediatric Graves' disease is associated with an unacceptable risk of liver failure... Read More

Jerome Groopman’s article in Wall Street Journal: “Why ‘Quality’ Care is Dangerous”. Is he right – or wrong? Or both?
2009-04-09 14:41:51
Submitted by: Dr. Richard Hellman
On April 8^th, the Wall Street Journal published an op-ed article by Jerome Groopman and Pamela Hartzband. The article was sharply critical of a reported effort of Medicare to tie pay-for-performance incentives to quality metrics that they have Read More

The NICE-SUGAR trial and the implications for clinical practice settings – Can We Generalize the Findings?
2009-04-06 16:26:12
Submitted by: Dr. Richard Hellman
The strength of any multi-center RCT such as the NICE-SUGAR trial lies in the large number of subjects. The statistical power of the large number of subjects with similar outcomes lowers the probability that the outcome could have occurred by chance. Read More

The NICE-SUGAR Study on Intensive versus Conventional Glucose control-The Importance of Patient Safety in Achieving the Desired Outcomes
2009-03-25 15:56:43
Submitted by: Dr. Richard Hellman
The long-awaited NICE-SUGAR trial results have just been published on-line in the New England Journal of Medicine, together with an excellent editorial by Inzucchi and Siegel. The ADA and AACE have also released a joint statement. Read More

Patient Safety and Racial and Ethnic Disparities
2009-02-27 08:43:18
Submitted by: Dr. Richard Hellman
The Third National Leadership Summit on Eliminating Racial and Ethnic Health Disparities was held on February 25-27, 2009, in National Harbor, Maryland. The conference has been widely anticipated and lived up to expectations. Read More

When do Medicare Payment Policies Potentially Threaten Patient Safety? A Potential Example: Proposed Payment Policies for Measurement of 25-OH Vitamin D Levels
2009-02-26 16:32:48
Submitted by: Dr. Richard Hellman
A draft Local Coverage Determination (LCD) was issued by one of the regional CMS carriers this month on payment codes for calcifediol (25-OH Vitamin D-3) levels. In this LCD, they delineated the diagnosis codes that would be paid for if the 25-OH vitamin Read More

How Important is Overconfidence in the Generation of Diagnostic Errors?
2009-02-26 16:30:29
Submitted by: Dr. Richard Hellman
Few patients tolerate uncertainty and hesitancy in their physician. The confident physician generates respect, admiration, and a following from their patients, staff and colleagues. But when does confidence in their own diagnostic acumen become a liabili Read More

Safety in the ICU - Is Bedside Glucose Testing Safe For Our Patients?
2009-02-25 09:56:39
Submitted by: Richard Hellman, MD, FACP, FACE
In my recent editorial on the NICE-SUGAR study, I raised the question as to whether the methods commonly used to measure glucose levels at the bedside may be the source of error that may pose a hazard to the patient. Read More

Preliminary Report of the NICE-SUGAR study:
Hypoglycemia and what it may mean for patient safety
2009-02-23 18:22:16
Submitted by: Richard Hellman, MD, FACP, FACE
The optimal treatment for the hyperglycemic patient in an ICU setting has been hotly debated for many years. On one side are those who propose that normoglycemia is the goal of treatment of hyperglycemia, and on the other side those who propose that the c Read More

Editorial on FDA alert on confusion between propylthiouracil (PTU) and purinethol (mercaptopurine)
2009-01-09 13:41:28
Submitted by: Dr. Richard Hellman
The FDA has just released an important alert from the Institute for Safe Medication Practices (ISMP) of yet another example of errors in drug administration due to confusion between two very different agents, a drug used to treat hyperthyroidism, PTU, and Read More

Joint Commission Safety Alert regarding Health Information Technology
2008-12-23 16:05:42
Submitted by: Dr. Richard Hellman
On December 11, 2008, the Joint Commission released a sentinel event alert regarding implementation of health information technology (HIT) and converging technologies – the interrelationship between medical devices and information technology. Read More

Editorial regarding interview with Carolyn Clancy, MD
2008-12-08 14:41:11
Submitted by: Dr. Richard Hellman
The Patient Safety Exchange is proud to begin what we hope is a long-running series of interviews with experts in the field of patient safety. Read More

The Obama Victory - How it May Affect Patient Safety Efforts in the US
2008-11-07 10:43:34
Submitted by: Richard Hellman, MD, FACP, FACE
Even those who did not vote for Senator Obama understand that his victory was of historic importance in the US, not only in repairing racial relations, but in choosing a direction of governance at a crucial time in our history. Read More

Should we change the rules for new drug approval to include cardiovascular outcomes in diabetes medications?
2008-09-11 13:49:57
Submitted by: Richard Hellman, MD, FACP, FACE

The JDRF Study on Continuous Glucose Monitoring
2008-09-08 14:23:42
Submitted by: Richard Hellman, MD, FACP, FACE

Additional Thoughts on ACCORD and ADVANCE Trials
2008-09-08 13:42:29
Submitted by: Richard Hellman, MD, FACP, FACE